MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-19 for CARE-E-VAC 3 758000 manufactured by Ohio Medical Llc.
[128399424]
(b)(4) was initiated for correction of other potentially affected devices.
Patient Sequence No: 1, Text Type: N, H10
[128399425]
Device was subject to (b)(4), and user facility noticed smoking, and upon device return to manufacturer it was noted that wires were in fact burned. The root cause was found to be the same as reason for field corrective action initiation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419185-2018-00009 |
| MDR Report Key | 8086683 |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-19 |
| Date Mfgr Received | 2018-10-19 |
| Device Manufacturer Date | 2018-05-03 |
| Date Added to Maude | 2018-11-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JESSICA BARRILE |
| Manufacturer Street | 1111 LAKESIDE DR |
| Manufacturer City | GURNEE IL 60031 |
| Manufacturer Country | US |
| Manufacturer Postal | 60031 |
| Manufacturer G1 | OHIO MEDICAL LLC |
| Manufacturer Street | 1111 LAKESIDE DR |
| Manufacturer City | GURNEE IL 60031 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CARE-E-VAC 3 |
| Generic Name | PORTABLE SUCTION DEVICE |
| Product Code | BTA |
| Date Received | 2018-11-19 |
| Model Number | 758000 |
| Catalog Number | 758000 |
| Lot Number | CEV318014 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHIO MEDICAL LLC |
| Manufacturer Address | 1111 LAKESIDE DR GURNEE IL 60031 US 60031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-19 |